Sleep Hygiene Education, ReadiWatchTM Actigraphy, and Telehealth Cognitive Behavioral Training for Insomnia Effect, on Symptom Relief for Men With Prostate Cancer Receiving Androgen Deprivation Therapy
NCT05582759 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2024-05-17
Summary
Many treatments for prostate cancer can cause significant fatigue and/or problems with memory and concentration. Many treatments for prostate cancer also result in disturbed sleep. Improving sleep may reduce feelings of fatigue and improve memory and concentration. The purpose of this study is to test a wearable device that provides real-time feedback on sleep patterns, instruction on how to improve sleep, and a score that indicates periods of time when fatigue and issues with memory and concentration may be most troublesome. The study also is designed to test a type of treatment (cognitive behavioral therapy for insomnia, CBT-I) that is helpful for people who are experiencing disturbed sleep.
Conditions
- Prostate Cancer
- Sleep Disturbance
- Fatigue
- Cognitive Impairment
Interventions
- BEHAVIORAL
-
teleCBT-I + SH/ReadiWatchTM
Participants receive real time feedback on sleep metrics, education on sleep hygiene and a four-week virtual cognitive behavioral therapy for insomnia intervention
- BEHAVIORAL
-
SH/ReadiWatchTM
Participants receive real time feedback on sleep metrics and education on sleep hygiene
Sponsors & Collaborators
-
Oncology Nursing Society
collaborator OTHER -
University of Kansas Medical Center
lead OTHER
Principal Investigators
-
Jamie Myers, PhD · University of Kansas Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-24
- Primary Completion
- 2023-12-01
- Completion
- 2023-12-01
Countries
- United States
Study Locations
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